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July 04, 2015 11:31 PM ET

Pharmaceuticals

Company Overview of Breckenridge Pharmaceutical, Inc.

Company Overview

Breckenridge Pharmaceutical, Inc. researches, develops, and markets generic prescription products in various therapeutic categories. The company markets its products in various dosage forms, including tablets, capsules, soft gel capsules, liquids, suspensions, and powders. It also provides various medical foods for the dietary management of patients with therapeutic or chronic medical needs; and prenatal and dietary supplements. In addition, the company handles various aspects of business operations, including procurement, purchasing, inventory management, warehousing, distribution, transportation, and customer service support. It serves chains, managed care customers, wholesalers, and distr...

6111 Broken Sound Parkway NW

Suite 170

Boca Raton, FL 33487

United States

Founded in 1983

Phone:

561-443-3314

Fax:

561-989-9747

Key Executives for Breckenridge Pharmaceutical, Inc.

Director of Operations
Senior Vice President of Sales for New Jersey Office
Vice President of Finance for CT Office
Associate Director of Technical Services for CT Office
Compensation as of Fiscal Year 2015.

Breckenridge Pharmaceutical, Inc. Key Developments

Breckenridge Pharmaceutical, Inc. and Alembic Pharmaceuticals Limited Get Final ANDA Approval for Desvenlafaxine XR Tablets

Breckenridge Pharmaceutical, Inc. announced that Breckenridge and Alembic Pharmaceuticals Limited were granted final approval for their ANDA desvenlafaxine succinate extended-release tablets 50 mg and 100 mg, a generic version of Pristiq by Pfizer Inc. Breckenridge and Alembic filed their Paragraph IV ANDA on the first-to-file date and expect to share 180-day exclusivity with other ANDA first filers. Alembic Pharmaceuticals Limited is the sponsor and manufacturer of the ANDA, which will be marketed exclusively by Breckenridge. The Paragraph IV litigation with respect to the ANDA has been settled on terms that are confidential. The settlement includes a license effective prior to the expirations of the patents involved in the litigation. Further announcements will be made prior to product launch. Desvenlafaxine is a prescription drug that is indicated for the treatment of major depressive disorder. Desvenlafaxine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). The product will be available in 50 mg and 100 mg tablets. Breckenridge's latest patent challenge for desvenlafaxine succinate extended-release tablets 50 mg and 100 mg highlights its aggressive Paragraph IV strategy. Breckenridge currently has twenty-two ANDAs filed and pending with FDA that contain Paragraph IV patent challenges, and intends to continue that trend in the next several years, focusing on niche and first-to-file Paragraph IV opportunities with certain barriers to entry.

Breckenridge Pharmaceutical, Inc. Announces Approval for Repaglinide Tablets, USP

Breckenridge Pharmaceutical, Inc. announced the final approval by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for Repaglinide Tablets USP, which is being manufactured and supplied by Standard Chem. & Pharm. Co. Ltd. Taiwan, and will be available in 0.5mg, 1mg, and 2mg strengths. Repaglinide Tablets are AB rated to Prandin®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The product launch plans are being finalized and first shipment will occur shortly.

Breckenridge Pharmaceutical, Inc. Announces Paragraph IV ANDA Litigation with Boehringer Ingelheim for its ANDA Dabigatran Etexilate Mesylate Capsules

Breckenridge Pharmaceutical, Inc. announced that it has filed an ANDA with a Paragraph IV certification for dabigatran etexilate mesylate capsules EQ 75 mg and EQ 150 mg strengths, a generic version of Pradaxa® by Boehringer Ingelheim. On March 5, 2015, Boehringer Ingelheim filed a Paragraph IV lawsuit against Breckenridge in the United States District Court for the District of New Jersey. Breckenridge filed its Paragraph IV ANDA on the first-possible submission date and expects to be entitled to 180-day exclusivity. Pradaxa® is a prescription drug that is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

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